Use of Degarelix in Controlled Ovarian Hyperstimulation (COH) Protocol for Women With PoliCystic Ovarian Syndrome (PCOS)

Centre for Endocrinology and Reproductive Medicine, Italy

Status and phase: Completed; Phase 3

Conditions: PCOS; OHSS; INFERTILITY

Treatments: Drug: degarelix (long acting GnRH antagonist); Drug: cetrorelix 0.25mg

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01709942

C05

Details and patient eligibility

About

In this study the effectiveness of degarelix, a long acting GnRH antagonist administered in a unique administration of 20 mg the first day of menstrual cycle, to prevent ovarian hyperstimulation syndrome (OHSS) in PCOS women at risk to develop OHSS.

Full description

Women with PCOS are at risk to develop OHSS when stimulated with gonadotrophins for IVF. For this reason in this study the degarelix was tested in order to minimize the risk of OHSS as well as to improve the pregnancy rate in these patients. The use of long acting GnRH antagonist promotes a deep suppression of LH and consequently the activity of theca cells, which secrete androgens (the precursors of estradiol), and consequently the levels of estradiol remains low. Comparing the long acting GnRH antagonist at the first day of cycle with a flexible GnRH antagonist protocol in a group of patients with PCOS will be useful in order to establish the best way to perform controlled hyperstimulation in IVF cycles and minimize the risk of OHSS.

Enrollment: 80 patients

Sex: Female

Ages: 20 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women with PCOS
• previous OHSS
• Infertility

Exclusion criteria

• more than 38 years old
• Body mass index pore than 30
• other systemic diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

degarelix group

Experimental group

Description:

group of patients treated with long acting GnRH antagonist

Treatment:

Drug: degarelix (long acting GnRH antagonist)

Cetrorelix 0.25mg

Active Comparator group

Description:

patients treated with gonadotropin and Cetrorelix ina flexible GnRH antagonist protocol

Treatment:

Drug: cetrorelix 0.25mg